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A phase I trial to evaluate the safety and tolerability of ALS-357 when administered for four weeks as a topical ointment, in escalating doses, to patients with cutaneous metastatic melanoma and to evaluate the effect of escalating doses of topically applied ALS-357 on histological remission of cutaneous metastatic melanoma and induction of apoptotic biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | ALS-357 applied topically twice weekly for four weeks. |
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| 2 | Experimental | ALS-357 applied topically every other day for four weeks. |
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| 3 | Experimental | ALS-357 applied topically once daily for four weeks. |
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| 4 | Experimental | ALS-357 applied topically twice daily for four weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALS-357 | Drug | Topical application of ALS-357 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and tolerability of ALS-357 when administered for four weeks as a topical ointment, in escalating doses, to patients with cutaneous metastatic melanoma. | Day 8, 15, 22, 29 and 43 | |
| Evaluate the effect of escalating doses of topically applied ALS-357 on histological remission of cutaneous metastatic melanoma and induction of apoptotic biomarkers. | Day 8, 15, 22, 29 and 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate differences in induction of apoptosis in treated versus control lesions via TUNEL assay. | Day 15, 29 and 43 | |
| Nucleic Acid will be isolated from portions of the biopsies to be utilized for gene expression profiling by various analytical platforms and correlated with other apoptotic in situ and surface protein expression pathways. |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Timothy Kuzel, MD | Contact | 312-695-1301 |
| Name | Affiliation | Role |
|---|---|---|
| Timothy Kuzel, MD | Robert H. Lurie Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| Day 15, 29 and 43 |
| Evaluate the plasma concentration of ALS-357 at each scheduled study visit. | Day 1, 8, 15, 22, 29 and 43 |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |